Quality study design and data collection is not new to medical research but with evolving methods, security needs and regulatory requirements, a research center at the Yale School of Public Health is expanding its data coordination capabilities for principal investigators at Yale and beyond.
Established in 2010, the Yale Center for Analytical Sciences (YCAS) has announced the opening of its Yale Data Coordinating Center (YDCC) to support the unique needs of multi-center clinical research studies.
YCAS is a center for collaborative science that was developed in partnership with Yale Center for Clinical Investigation and the Yale School of Public Health. With expertise in biostatistics, epidemiology, clinical trials and informatics along with a highly trained technical staff skilled in systems programming, data management, data analysis and statistical programming, the group designs and conducts single and multicenter clinical trials, longitudinal cohort studies, case control studies and other observational studies.
The YDCC offers investigators comprehensive coordination including study design, data management (including design and implementation of data management systems, data entry, quality control and security), data monitoring and statistical analysis.
“There are a lot of logistical hurdles in the design, data collection and monitoring of clinical research studies which YDCC is equipped to handle,” says James Dziura, MPH, PhD, Associate Professor of Emergency Medicine as well as Deputy Director, Yale Center for Analytical Sciences.“In this environment of heightened regulatory oversight, it is important to have the right expertise supporting large multi-million dollar studies and the role they carry in translational science.”
Among current studies that YDCC manages are the:
Integrated Stepped Care for Unhealthy Alcohol Use in HIV – a multi-center randomized trial. Data management services include setting up data entry screens for web-based remote data entry, training coordinators on the data entry system including the use of the subject calendar to track individual subjects and the preparing data quality reports within each site. The YDCC also prepares Data and Safety Monitoring Board reports and data analytic files, and collaborates with clinical leadership to carryout statistical analysis.
Guanfacine for the Treatment of Hyperactivity in Pervasive Developmental Disorder – YDCC provides overall coordination for a multicenter randomized, double-blind, placebo-controlled trial, including management of regulatory matters (protocol history, protocol amendments, IRB approvals, DSMB correspondence), data management (data entry screens for remote data entry, training coordinators on data entry system and on the use of a subject calendar to track individual subjects and data quality within each site) and biostatistical services (quarterly Data and Safety Monitoring Board reports, study data for analysis). YDCC biostatisticians collaborate with the clinical leadership to carryout statistical analysis.
For more information, contact James.Dziura@yale.edu. (Phone: 203.737.5946, ycas.yale.edu).